FDA 510(k) Application Details - K061008

Device Classification Name	Respiratory Syncytial Virus - Elisa   More FDA Info for this Device
510(K) Number	K061008
Device Name	Respiratory Syncytial Virus - Elisa
Applicant	QUIDEL CORP. 10165 MCKELLAR CT. SAN DIEGO, CA 92121 US Other 510(k) Applications for this Company
Contact	JOHN D TAMERIUS Other 510(k) Applications for this Contact
Regulation Number	866.3480   More FDA Info for this Regulation Number
Classification Product Code	MCE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/12/2006
Decision Date	09/08/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review